Product Compliance Specialist
Siemens Healthineers
Summary
Varian Medical Systems, a Siemens Healthineers company is seeking an onsite Product Compliance Specialist at our Headquarters in Palo Alto, California. This role will allow some remote/hybrid flexibility but the successful applicant should be prepared to be onsite several days per week.
Job description
The Product Compliance Specialist is responsible for ensuring global product compliance and certification throughout the product lifecycle, from concept and development through commercialization and obsolescence. This role serves as the subject matter expert for product safety, EMC, and applicable regulatory standards, partnering closely with Engineering, Quality, Regulatory Affairs, and external certification agencies to maintain compliance for medical device products.
Product Safety & EMC Compliance
- Determine applicable regulatory requirements and standards for new and existing products.
- Provide product safety and EMC guidance based on standards expertise, interpretation, and research.
- Support safety and EMC investigations throughout the product lifecycle.
- Communicate compliance requirements and design considerations to cross-functional and hardware engineering teams.
- Participate in risk management reviews and product safety assessments.
- Support compliance activities from product development through end-of-life.
Regulatory & Certification Management
- Coordinate testing activities with third-party laboratories and certification bodies.
- Support global product approvals and ongoing certification maintenance.
- Assist with regulatory agency inspections and quarterly Follow-Up Services (FUS) activities.
- Maintain compliance records, certifications, and technical documentation.
- Ensure continued compliance with applicable global regulatory and industry standards.
Cross-Functional Partnership
- Work closely with Engineering, Quality, Regulatory Affairs, and Product Management teams.
- Communicate compliance status, test results, and certification updates throughout all design phases.
- Provide technical recommendations related to product safety, EMC, and certification requirements.
- Support issue resolution related to product compliance and certification activities.
Standards & Technical Expertise
- Apply expertise in medical electrical safety and EMC standards to support product development efforts.
- Interpret standards requirements and translate them into actionable technical requirements.
- Support compliance strategies for new product introductions and design changes.
- Assist with investigations related to EMC, EMI, and product safety concerns.
Requirements
- Bachelor's degree in Electrical Engineering, Mechanical Engineering, or a related technical discipline.
- 5+ years of experience in product compliance, EMC, electrical safety, or related compliance functions.
- Experience managing product compliance activities and obtaining global certifications.
- Experience working with medical electrical safety and EMC standards, including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-1.
- Proven experience obtaining NRTL approvals for medical devices.
- Knowledge of electronics, mechanical design, and product safety principles.
- Experience working with third-party testing and certification laboratories.
- Experience developing and documenting technical requirements based on regulatory and industry standards.
- Proficiency with Microsoft Office applications, including Excel.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement plan
- Life insurance
- Long-term disability insurance
- Short-term disability insurance
- Paid parking
- Public transportation
- Paid time off
- Paid sick and safe time
Company overview
Siemens Healthineers is a German multinational medical technology company specializing in diagnostic and therapeutic imaging, laboratory diagnostics, and molecular medicine. Founded in 2017 as a spin-off from Siemens AG, the company has established itself as a global leader in healthcare technology with a comprehensive portfolio that addresses the complete care continuum for many of the world's most threatening diseases. With approximately 69,500 employees worldwide and operations in over 70 countries, Siemens Healthineers generates annual revenues exceeding €21 billion. The company's product offerings span across four main business segments: Imaging (including CT, MRI, ultrasound, and X-ray systems), Diagnostics (laboratory and point-of-care testing), Varian (cancer care and radiation therapy), and Advanced Therapies. Siemens Healthineers is particularly renowned for pioneering breakthroughs in medical imaging, having developed the world's first commercial PET/CT scanner and continuing to innovate in areas such as artificial intelligence, digital health solutions, and precision therapy. The company's commitment to research and development, with annual investments of approximately €1.5 billion, drives its mission to pioneer breakthroughs in healthcare for everyone, everywhere, sustainably.